Hydroxychloroquine in Giant Cell Arteritis
Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.
2 other identifiers
interventional
75
1 country
23
Brief Summary
Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2002
Longer than P75 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 31, 2007
CompletedFirst Posted
Study publicly available on registry
February 2, 2007
CompletedOctober 6, 2015
October 1, 2015
3 years
January 31, 2007
October 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
prednisone dosage equal to or lower than 5 mg since more than 3 months without
3 months at least
having experienced relapse since the inclusion in the study
Secondary Outcomes (2)
prednisone daily dosage
6, 12, 18 and 24 months
hydroxychloroquine blood levels
Interventions
Eligibility Criteria
You may qualify if:
- giant celle arteritis with at least 3 ACR criteria including a disgnostic temporal artery biopsy
- corticosteroid treatment since less than 1 month
- age less than 85 years
- signed informed consent
You may not qualify if:
- amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium infarctus, mesenteric ischemia or other vascular complications related to GCA
- low life expectancy (\<2 years)
- corticosteroid treatment since more than 30 days whatever the dosage
- primary corticosteroid resistance defined by persistant symptoms despite prednisone for more than 15 days
- previous psychiatric troubles induced corticosteroids
- hydroxychloroquine contra-indicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Hospital
Agen, 47923, France
Hospital
Albi, 81000, France
Hospital Auch
Auch, 32008, France
Hospital Avignon
Avignon, 84902, France
University Hospital Besançon
Besançon, 25030, France
Hospital Béziers
Béziers, 34525, France
University Hospital Côte de Nacre
Caen, 14033, France
University Hospital Dijon
Dijon, 21035, France
Hospital
Foix, 09017, France
Hospital
Lavaur, 81500, France
University Hospital Dupuytren
Limoges, 87042, France
Hospital
Lisieux, 14100, France
Hospital
Lourdes, 65107, France
Hospital
Mazamet, 81200, France
Hospital
Montauban, 82013, France
University Hospital
Nantes, 44035, France
Saint Louis Hospital
Paris, 75010, France
University Hospital Saint Antoine
Paris, 75012, France
University Hospital Bichat
Paris, 75018, France
Hospital Suresnes
Suresnes, 92151, France
University Hospital Toulouse
Toulouse, 31059, France
University Hospital
Toulouse, 31059, France
University Hospital Bretonneau
Tours, 37044, France
Related Publications (6)
Jover JA, Hernandez-Garcia C, Morado IC, Vargas E, Banares A, Fernandez-Gutierrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Jan 16;134(2):106-14. doi: 10.7326/0003-4819-134-2-200101160-00010.
PMID: 11177313BACKGROUNDChevalet P, Barrier JH, Pottier P, Magadur-Joly G, Pottier MA, Hamidou M, Planchon B, El Kouri D, Connan L, Dupond JL, De Wazieres B, Dien G, Duhamel E, Grosbois B, Jego P, Le Strat A, Capdeville J, Letellier P, Agron L. A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients. J Rheumatol. 2000 Jun;27(6):1484-91.
PMID: 10852275BACKGROUNDMazlumzadeh M, Hunder GG, Easley KA, Calamia KT, Matteson EL, Griffing WL, Younge BR, Weyand CM, Goronzy JJ. Treatment of giant cell arteritis using induction therapy with high-dose glucocorticoids: a double-blind, placebo-controlled, randomized prospective clinical trial. Arthritis Rheum. 2006 Oct;54(10):3310-8. doi: 10.1002/art.22163.
PMID: 17009270BACKGROUNDLe Guennec P, Dromer C, Sixou L, Marc V, Coustals P, Fournie B. [Treatment of Horton disease. Value of synthetic antimalarials. Apropos of a retrospective study of 36 patients]. Rev Rhum Ed Fr. 1994;61(7-8):485-90. French.
PMID: 7833883BACKGROUNDDavid-Chausse J, Dehais J, Leman A. [Results of a regional survey on the treatment of rhizomelic pseudopolyarthritis and temporal arteritis. Apropos of 242 cases treated by various modalities with synthetic antimalarials, corticoids and non-steroidal anti-inflammatory agents]. Rev Rhum Mal Osteoartic. 1983 Jul-Sep;50(8-9):563-71. French.
PMID: 6635510BACKGROUNDHoffman GS, Cid MC, Hellmann DB, Guillevin L, Stone JH, Schousboe J, Cohen P, Calabrese LH, Dickler H, Merkel PA, Fortin P, Flynn JA, Locker GA, Easley KA, Schned E, Hunder GG, Sneller MC, Tuggle C, Swanson H, Hernandez-Rodriguez J, Lopez-Soto A, Bork D, Hoffman DB, Kalunian K, Klashman D, Wilke WS, Scheetz RJ, Mandell BF, Fessler BJ, Kosmorsky G, Prayson R, Luqmani RA, Nuki G, McRorie E, Sherrer Y, Baca S, Walsh B, Ferland D, Soubrier M, Choi HK, Gross W, Segal AM, Ludivico C, Puechal X; International Network for the Study of Systemic Vasculitides. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum. 2002 May;46(5):1309-18. doi: 10.1002/art.10262.
PMID: 12115238BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ARLET Philippe, D
CHU Toulouse, Hôpital Purpan
- STUDY DIRECTOR
SAILLER Laurent, MD
CHU Toulouse, Service de Médecine Interne, Hôpital Purpan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2007
First Posted
February 2, 2007
Study Start
January 1, 2002
Primary Completion
January 1, 2005
Study Completion
December 1, 2006
Last Updated
October 6, 2015
Record last verified: 2015-10